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Diet and Physical Activity for Prostate Cancer

N/A

Recruiting

Led By Marian L. Neuhouser

Research Sponsored by Fred Hutchinson Cancer Research Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 40-70 years

Primary treatment is RT + ADT [Zoladex, Lupron, Degarelix, and other luteinizing hormone-releasing hormone (luteinizing hormone releasing hormone [LHRH])-directed therapies] with standard RT dose and fractionation (anti-androgen monotherapy will not be allowed

Must not have

Advanced, metastatic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at whether a diet and exercise intervention can improve blood measures of lipids and insulin resistance in prostate cancer patients undergoing radiation therapy and androgen deprivation therapy.

Who is the study for?

Men aged 40-70 with prostate cancer set to receive radiation and hormone therapy can join. They must have a specific type of prostate cancer (adenocarcinoma), be physically able to exercise, and not already planning to start a diet or fitness program. Men with severe diabetes, recent heart attacks or strokes, cognitive issues, substance abuse problems, or advanced cancer cannot participate.

What is being tested?

The trial is testing if changing diet and increasing physical activity can prevent negative changes in metabolism caused by hormone therapy for prostate cancer. It looks at how these lifestyle changes affect blood lipids, insulin resistance, body composition, muscle health, and overall quality of life during treatment.

What are the potential side effects?

Since the intervention involves dietary changes and exercise rather than medication there are no typical 'side effects' like you'd expect from drugs; however participants may experience discomfort from new exercise routines or challenges adjusting to dietary restrictions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 40 and 70 years old.

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I am receiving hormone therapy and radiation for my cancer.

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My prostate cancer is confirmed and considered intermediate or high risk.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to other parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Effects of the intervention on ADT-induced changes in body weight

Effects of the intervention on ADT-induced changes in fat mass

Effects of the intervention on ADT-induced changes in lean mass

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group I (diet, physical activity)Experimental Treatment4 Interventions

Patients attend 10 in-person or virtual sessions with a registered dietician over 6 months to receive diet instructions. Patients also attend 2 one-on-one sessions with an exercise psychologist to receive instruction to complete aerobic physical activity and strength/resistance training. Patients may also complete up to 21 additional supervised exercise sessions.

Group II: Group II (standard lifestyle recommendations)Active Control3 Interventions

Patients receive standard lifestyle recommendations and attend an individual session with a dietitian over 20-30 minutes including US dietary guidelines, activity goal of 30 minutes of physical activity 5 days/week; and discussion of the health benefits of weight loss along with general behavior change suggestions for weight loss.

0 / 4Eligibility criteria met